Control of continuous processes for production of biopharmaceutical products

Abstract

With the advent of continuous manufacturing (CM), there is growing interest in development of mechanistic or statistical model-based control strategies. CM has been successfully implemented in the pharmaceutical and food industry owing to the numerous advantages it offers. Over the past decade, there have been considerable developments towards creating technology solutions for performing bioprocess unit operations in continuous mode. Continuous mode has shown superiority in terms of specific productivity and consumable utilization. Hardware for performing continuous processing is available today, often from multiple technology providers. Challenges arise, however, when implementing continuous processing. A major hurdle is process control, as controlling a continuous process is considerably more complex than controlling a batch process. In this article, we focus on recent developments on the topic of control of continuous processing for production of biopharmaceuticals. Hurdles that continue to exist have also been highlighted.